FDA Remanufacturing Guidance
The Corner Office
Wayne Moore
5/13/2024
As readers know, the FDA recently released the long-awaited final Guidance for Remanufacturing.1 Overall, the FDA took the path of outlining the requirement for servicers and repair entities (excluding hospital-based HTMs) to employ risk-based analysis of repair activities coupled with quantitative testing to determine either if the “repair” activity was returning the device to manufacturers specifications, or if it was significantly changing the safety, efficacy, or intended clinical use of the device. The former being a repair activity, the latter being a remanufacturing activity. In this context, service entities do not need to register with the FDA, but remanufacturers do.
The Guidance is focused on what the obligations are for ISO 3rd party servicers and OEMs who are acting as 3rd party servicers to ensure they are not crossing the line from routine maintenance and servicing into remanufacturing. As the FDA says in the Guidance on Page 3, “Irrespective of an entity’s self-identified designation as a “servicer” or “remanufacturer,” FDA focuses on the specific activities an entity performs on a particular device.13 The determination of whether the activities an entity performs are remanufacturing affects the applicability and enforcement of regulatory requirements under the FD&C Act and its implementing regulations. FDA has consistently enforced requirements under the FD&C Act and its implementing regulations on entities engaged in remanufacturing, including but not limited to registration and listing, adverse event reporting, the Quality System (QS) regulation, and marketing submissions.”
Acertara is delighted that the FDA has finally released this Guidance as it is focused on one thing, and it’s the most important thing, patient safety.
Until next month,
Wayne